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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE: 11,714 Adverse Event Reports & Safety Profile

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11,714
Total FAERS Reports
1,069 (9.1%)
Deaths Reported
809
Hospitalizations
11,714
As Primary/Secondary Suspect
89
Life-Threatening
2,828
Disabilities

Active Ingredient: ACETAMINOPHEN\OXYCODONE HYDROCHLORIDE\OXYCODONE TEREPHTHALATE ·

First Report: 19740324 · Latest Report: 20250225

What Are the Most Common ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE Side Effects?

#1 Most Reported
Drug dependence
10,040 reports (85.7%)
#2 Most Reported
Pain
5,701 reports (48.7%)
#3 Most Reported
Emotional distress
5,416 reports (46.2%)

All ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug dependence 10,040 85.7% 832 596
Pain 5,701 48.7% 154 215
Emotional distress 5,416 46.2% 115 128
Drug withdrawal syndrome 4,618 39.4% 208 185
Overdose 4,000 34.2% 647 330
Anxiety 1,001 8.6% 88 165
Foetal exposure during pregnancy 841 7.2% 18 35
Drug withdrawal syndrome neonatal 830 7.1% 21 31
Drug abuse 770 6.6% 142 161
Depression 766 6.5% 112 179
Developmental delay 578 4.9% 9 37
Death 553 4.7% 551 31
Learning disability 549 4.7% 9 38
Mental disorder 533 4.6% 48 63
Maternal exposure during pregnancy 470 4.0% 36 41
Disability 329 2.8% 25 75
Withdrawal syndrome 329 2.8% 40 58
Insomnia 290 2.5% 53 84
Unevaluable event 279 2.4% 25 54
Vomiting 267 2.3% 49 86

Who Reports ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE Side Effects? Age & Gender Data

Gender: 43.3% female, 56.7% male. Average age: 44.6 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 23 6 6
2001 22 6 6
2002 25 6 7
2003 20 3 9
2004 26 8 7
2005 28 14 10
2006 39 16 12
2007 43 13 12
2008 46 11 14
2009 30 7 10
2010 50 13 17
2011 54 23 17
2012 50 19 13
2013 49 23 15
2014 69 33 16
2015 91 39 23
2016 100 36 24
2017 114 52 33
2018 80 35 22
2019 88 46 25
2020 36 18 9
2021 5 4 1
2022 7 0 4
2023 9 1 2
2024 2 1 0
2025 1 0 0

View full timeline →

What Is ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE Used For?

IndicationReports
Product used for unknown indication 9,527
Pain 1,108
Back pain 183
Pain management 75
Back injury 67
Breakthrough pain 54
Injury 51
Arthralgia 38
Foetal exposure during pregnancy 33
Surgery 33

ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs Alternatives: Which Is Safer?

ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACETAMINOPHEN\PROPOXYPHENE ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACETAMINOPHEN\PSEUDOEPHEDRINE ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACETAMINOPHEN\TRAMADOL ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACETAZOLAMIDE ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACETYLCYSTEINE ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACETYLLEUCINE ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACETYLLEUCINE, L- ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACETYLSALICYLIC ACID ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACITRETIN ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE vs ACLARUBICIN

Official FDA Label for ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE

Official prescribing information from the FDA-approved drug label.